Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
22. februar 2021 opdateret af: Gilead Sciences
An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)
The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
90
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Cardiff, Det Forenede Kongerige, CF14 4XW
- University Hospital of Wales
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Leicester, Det Forenede Kongerige, LE1 5WW
- Leicester Royal Infirmary
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Plymouth, Det Forenede Kongerige, Pl6 8DH
- Derriford Hospital
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Lille, Frankrig, 59037
- CHRU - Hôpital Claude Huriez
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Lyon, Frankrig, 69495
- Centre Hospitalier Lyon Sud
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Montpellier, Frankrig, 34295
- CHU St Eloi
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- Males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of curative or high priority exists and for whom treatment with a Btk inhibitor may be deemed appropriate.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Key Exclusion Criteria:
- Central nervous system (CNS) lymphoma.
- Women who are pregnant or lactating.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Tirabrutinib 20 mg Once Daily (CLL)
Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 40 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
|
Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 80 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
|
Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 160 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
|
Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 320 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 400 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 500 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 600 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 300 mg Twice Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 20 mg Once Daily (NHL)
Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 40 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
|
Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
|
Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
|
Capsules administered orally
Andre navne:
|
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Eksperimentel: Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
|
Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
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Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
|
Capsules administered orally
Andre navne:
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Eksperimentel: Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
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Capsules administered orally
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Experiencing Dose-Limiting Toxicities
Tidsramme: Day 1 through Day 28
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Dose Limiting Toxicities (DLT) were defined as follows:
Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT. |
Day 1 through Day 28
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Response Rate
Tidsramme: Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months)
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Overall response rate (ORR) was defined as the percentage of participants who achieve a best overall response of complete remission (CR, unconfirmed complete response (CRu), complete response with incomplete marrow recovery (CRi)) or partial remission (PR, nodal PR) during study as assessed by the investigator. ORR assessment was defined per following standardized criteria:
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Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months)
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Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib
Tidsramme: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
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Cmax is defined as the maximum concentration of drug.
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Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
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PK Parameter: AUCtau of Tirabrutinib
Tidsramme: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
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AUCtau is defined as concentration of drug over dosing interval.
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Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.
- Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674. No abstract available.
- Fegan, C, Bagshawe J, Salles G, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity and well tolerated in patients with high risk chronic lymphocytic leukaemia (CLL). Paper presented at: 56th American Society of Hematology Annual Meeting and Exposition; December 6-9, 2014; San Franscisco, CA.
- Morschhauser F, Terriou L, Dyer M, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity in patients with relapsed and refractory NHL. Haematologica. 2014 Jun; 99: 150.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. august 2012
Primær færdiggørelse (Faktiske)
23. februar 2015
Studieafslutning (Faktiske)
11. januar 2016
Datoer for studieregistrering
Først indsendt
6. juli 2012
Først indsendt, der opfyldte QC-kriterier
6. august 2012
Først opslået (Skøn)
7. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ONO-4059POE001
- 2011-005033-39 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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